A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

Phase 1

• Conditions: Diabetes in Adults
• Interventions: Drug: HR011408 injection

• Registration Number: NCT05147259
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Study Start: 2021-11-29
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-07
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female aged 18-55 years(both inclusive) at the time of signing informed consent
2. Body mass index 18.0-26.0kg/m2(both inclusive)
3. Body weight ≥50.0kg(male),≥45.0kg(female)
4. Fasting serum/plasma glucose <6.1mmol/L

Exclusion Criteria

1. Known or suspected of being allergic to any ingredient in the study drug.
2. Participated in any drug or medical device-related clinical trial within 3 months before screening.
3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration
4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.
5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort one: Low dose	HR011408 injection	Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
Cohort two: Medium dose	HR011408 injection	Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
Cohort three: high dose	HR011408 injection	Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	from Day1 to Day15	The incidence of adverse events will be collected and the safety of HR011408 will be assessed
Area under the concentration-time curve (AUC)	from 0 to 10 hours after dose administration	Area under the concentration-time curve (AUC)
Maximum observed concentration (Cmax)	from 0 to 10 hours after dose administration	Maximum observed concentration (Cmax)
Elimination half-life (t1/2)	from 0 to 10 hours after dose administration	Elimination half-life (t1/2)
Time to maximum observed concentration (Tmax)	from 0 to 10 hours after dose administration	Time to maximum observed concentration (Tmax)
Onset of appearance	from 0 to 10 hours after dose administration	First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Time to 50% maximum observed concentration (time to 50% Cmax)	from 0 to 10 hours after dose administration	Time to 50% maximum observed concentration (time to 50% Cmax)

Secondary Outcome Measures

Name	Time	Method
Assessment of development of Anti-drug Antibodies (ADAs)	from Day1 to Day15 after dose administration	Incidence of Anti-drug Antibodies (ADAs) will be assessed